CN115317072A

CN115317072A - Intravascular imaging shock wave balloon catheter and medical equipment

Info

Publication number: CN115317072A
Application number: CN202210955952.3A
Authority: CN
Inventors: 陈亮亮; 白晓淞
Original assignee: Innermedical Co ltd
Current assignee: Innermedical Co ltd
Priority date: 2022-08-10
Filing date: 2022-08-10
Publication date: 2022-11-11

Abstract

The invention provides an intravascular imaging shock wave balloon catheter and medical equipment. The balloon catheter comprises: an outer tube; the balloon is positioned at the distal end of the outer tube and is communicated with the outer tube; the inner tube is arranged in a cavity formed by the outer tube and the balloon in a penetrating way, and the far end of the inner tube is exposed out of the far end of the balloon; the imaging probe is positioned in the inner tube and in the part of the inner tube exposed out of the balloon, and the imaging probe acquires imaging signals; the spring tube is positioned in the inner tube, the far end of the spring tube is connected with the imaging probe, and the near end of the spring tube is connected with the driving structure and used for driving the imaging probe to move; and the electrode is positioned on the outer surface of the inner pipe, positioned in the balloon and connected with the high-voltage pulse output module, and after the conductive liquid is filled in the balloon, the electrode punctures the nearby conductive liquid under the action of the high-voltage pulse to generate mechanical shock waves in the balloon. Therefore, intravascular imaging can be performed on the diseased blood vessels, and shock wave therapy can also be performed. The flow of the shock wave treatment operation is obviously simplified, and the harm of the operation to the patient can be reduced.

Description

Intravascular imaging shock wave balloon catheter and medical equipment

Technical Field

The embodiment of the invention relates to the technical field of medical instruments, in particular to an intravascular imaging shock wave balloon catheter and medical equipment.

Background

Atherosclerosis is the main cause of coronary heart disease, cerebral infarction and peripheral vascular disease, and is characterized by fibrous tissue hyperplasia and calcinosis, gradual disintegration and calcification of middle layer of artery, thickening and hardening of arterial wall and narrowing of vascular cavity. The tissue or organ supplied by the artery will be ischemic or necrotic.

The intravascular shock wave lithotripsy (ISL) technique has begun to be applied clinically abroad as an emerging technique in recent years. The intravascular shock wave lithotripsy system mainly comprises an intravascular shock wave therapeutic apparatus and a shock wave balloon. The doctor delivers the shock wave saccule to the calcified lesion part of the blood vessel, then carries out low-pressure expansion on the shock wave saccule, finally starts the intravascular shock wave therapeutic apparatus to release high-pressure pulse to the shock wave saccule to generate shock wave, breaks the calcified plaque on the superficial layer and the deep layer of the blood vessel cavity, and fully expands the blood vessel cavity, thereby achieving the purpose of obviously improving the compliance of the blood vessel.

In the related scheme, before the vascular calcification lesion pretreatment is carried out by using the shock wave balloon, a doctor firstly uses an intravascular ultrasonic imaging catheter (IVUS) for detection to acquire data such as the lumen inner diameter of a target blood vessel. And then selecting a shock wave balloon with a proper specification according to the vascular lumen data of the patient so as to ensure the effect of shock wave treatment. After the shock wave treatment, the doctor uses the intravascular ultrasonic imaging catheter again to detect whether calcified lesions are broken or not, whether the lumen of the blood vessel is enlarged or not and whether the blood vessel can be implanted with the stent or not. After the stent is implanted, a doctor uses an intravascular ultrasonic imaging catheter to detect the luminal stenosis and the adherent condition of the stent, and evaluates the operation.

Obviously, in the related scheme, the function of the shock wave saccule is single, the detection and the treatment are two mutually separated processes, in the operation, the intravascular ultrasonic imaging catheter needs to be used for detection for many times, the operation time is long, the process is complicated, the operation efficiency is low, and the operation experience of a patient is not facilitated.

Disclosure of Invention

The embodiment of the invention provides an intravascular imaging shock wave balloon catheter and medical equipment, and aims to solve the technical problems that in the prior art, when a shock wave balloon is used for treatment, an intravascular ultrasonic imaging catheter needs to be used for detection for multiple times, the operation time is long, the process is complex, the operation efficiency is low, and the operation experience of a patient is not facilitated.

In order to solve the technical problem, the invention is realized as follows:

in a first aspect, there is provided an intravascular imaging shockwave balloon catheter comprising:

an outer tube;

a balloon at a distal end of the outer tube in communication with the outer tube;

an inner tube, which is arranged in a cavity formed by the outer tube and the balloon in a penetrating way, and the distal end of the inner tube is exposed out of the distal end of the balloon;

the imaging probe is positioned in the inner tube and the part of the inner tube, which is exposed out of the balloon, moves in the inner tube and acquires imaging signals;

the spring tube is positioned in the inner tube, the far end of the spring tube is connected with the imaging probe, and the near end of the spring tube is connected with the driving structure and used for driving the imaging probe to move;

the electrode is positioned on the outer surface of the inner tube and in the balloon, the electrode is connected with the high-voltage pulse output module, and after the conductive liquid is filled in the balloon, the electrode breaks down the nearby conductive liquid under the action of the high-voltage pulse to generate mechanical shock waves in the balloon.

Preferably, the method further comprises the following steps: the signal line is arranged in the spring tube, the far end of the signal line is connected with the imaging probe, the near end of the signal line is connected with the imaging device, and the signal line is used for transmitting the imaging signal.

Preferably, the method further comprises the following steps:

and the partition is arranged in the inner tube and arranged on one side of the imaging probe close to the far end of the inner tube and used for limiting the position of the imaging probe.

Preferably, the method further comprises the following steps:

the guide wire cavity is provided with a quick exchange port, is positioned in the inner cavity of the inner tube and is used for penetrating through the guide wire;

the guide wire can penetrate into or out of the guide wire cavity from the quick exchange port, and the guide wire is used for guiding the balloon catheter.

Preferably, the method further comprises the following steps:

a visualization ring located on the inner or outer surface of the inner tube, the visualization ring for visualizing a marker to mark the position of the balloon catheter.

Preferably, the method further comprises the following steps:

the wire is positioned on the outer wall of the inner tube, the far end of the wire is connected with the electrode, and the near end of the wire is connected with the high-voltage pulse output module and used for transmitting high-voltage pulses to the electrode.

Preferably, the method further comprises the following steps: the inner tube is a multi-layer thin-walled tube with a groove on the surface, and the lead is positioned in the groove of the inner tube.

Preferably, the method further comprises the following steps:

a catheter hub located at the proximal end of the outer tube and coupled to the outer tube, the catheter hub comprising: the catheter base filling cavity and the catheter base connecting cavity;

the catheter base connecting cavity is connected with the catheter base filling cavity;

the catheter hub filling cavity is used for injecting conductive liquid between the outer tube and the inner tube.

Preferably, the method further comprises the following steps:

the catheter adapter is connected with the catheter base connecting cavity through the catheter extension pipe; the catheter adapter is adapted to connect to at least one of: the driving structure, the high-voltage pulse output module and the imaging device.

Preferably, the method further comprises the following steps:

the imaging probe is an ultrasonic imaging probe.

In a second aspect, a medical device is provided, the medical device including the balloon catheter of the first aspect, further including: the device comprises a high-voltage pulse output module, an imaging device and a driving structure;

the balloon catheter further comprises: the high-voltage pulse output module is connected with the electrode through the lead;

the driving structure is connected with the spring tube and used for driving the imaging probe to move through the spring tube;

the balloon catheter further comprises: and the imaging device is connected with the signal line and is used for receiving the imaging signals acquired by the imaging probe through the signal line.

The intravascular imaging shock wave balloon catheter provided by the embodiment of the invention breaks through the single function of the traditional shock wave balloon catheter, and can be used for intravascular imaging and shock wave treatment of a diseased blood vessel by utilizing the imaging probe, the spring tube and a driving structure. Therefore, the operation of a doctor can be facilitated, the operation time is shortened, unnecessary medical instruments for operation are further reduced, the flow of the shock wave treatment operation is obviously simplified, the harm of the operation to a patient can be reduced, and the economic burden of the patient is reduced.

Drawings

Various additional advantages and benefits will become apparent to those of ordinary skill in the art upon reading the following detailed description of the preferred embodiments. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the invention. Also, like reference numerals are used to refer to like parts throughout the drawings. In the drawings:

fig. 1 is a schematic overall structure diagram of an intravascular imaging shockwave balloon catheter according to an embodiment of the present invention;

fig. 1 includes: a guide wire cavity 101, developing rings (102, 103), a quick exchange port 104, an imaging cavity 105, an imaging probe 106, a spring tube 107, an inner tube 108, electrodes (109, 110), guide wires (111, 112), a balloon 113, an outer tube 114, a catheter base filling cavity 115 and a catheter base connecting cavity 116;

FIG. 2 is a schematic diagram illustrating a connection relationship between an intravascular imaging shockwave balloon catheter and an external device according to an embodiment of the present invention;

fig. 2 includes: a conduit extension tube 117, a conduit adapter 118, a driving structure and a high-voltage pulse output module 119; an imaging device 120.

Detailed Description

The technical solutions of the present invention will be described clearly and completely with reference to the accompanying drawings, and it is to be understood that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without making any creative effort based on the embodiments in the present invention, belong to the protection scope of the present invention.

It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or be indirectly on the other element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or be indirectly connected to the other element.

It will be understood that the terms "length," "width," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like, as used herein, refer to an orientation or positional relationship indicated in the drawings, which is solely for the purpose of facilitating the description and simplifying the description, and do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and is therefore not to be construed as limiting the invention. Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present invention, "a plurality" means two or more unless specifically defined otherwise.

The various features and embodiments described in the embodiments may be combined in any suitable manner, for example, different embodiments may be formed by combining different features/embodiments, and in order to avoid unnecessary repetition, various possible combinations of features/embodiments in the present invention will not be described in detail.

The size and thickness of each component shown in the drawings are arbitrarily illustrated, and the present invention is not limited to the size and thickness of each component. The dimensions of the elements in the figures are exaggerated in part for clarity of illustration.

An embodiment of the present invention provides an intravascular imaging shock wave balloon catheter, as shown in fig. 1, the intravascular imaging shock wave balloon catheter includes:

an outer tube 114; a balloon 113 at the distal end of the outer tube 114, in communication with the outer tube 114; an inner tube 108 inserted into the chamber formed by the outer tube 114 and the balloon 113, and the distal end of the inner tube 108 is exposed out of the distal end of the balloon 113; an imaging probe 106 located in the inner tube 108 and in a region of the inner tube 108 where the balloon 113 is exposed; the imaging probe 106 performs a rotational and retracting movement in the inner tube 108 to acquire an imaging signal. A spring tube 107, which is located in the inner tube 108, and has a distal end connected to the imaging probe 106 and a proximal end connected to a driving structure (119 shown in fig. 2) for driving the imaging probe 106 to perform a uniform rotation motion or a pull-back motion; the

electrodes

109 and 110 are positioned on the outer surface of the inner tube 108 and positioned in the balloon 113, the

electrodes

109 and 110 are used for being connected with a high-voltage pulse output module 119 (shown in fig. 2), high-voltage pulses generated by the high-voltage pulse output module 119 are conducted to the

electrodes

109 and 110 through the

leads

111 and 112, and after the balloon 113 is filled with conductive liquid, the

electrodes

109 and 110 break down nearby conductive liquid under the action of the high-voltage pulses, so that mechanical shock waves are generated in the balloon 113.

It should be noted that the proximal end and the distal end of the present invention use an operator in operation as a reference frame, the end far away from the operator is the distal end, and the end close to the operator is the proximal end.

The outer tube 114 is disposed outside the inner tube 108, the balloon 113 is located at the distal end of the outer tube 114, the outer tube 114 and the balloon 113 form a sealed chamber in which the inner tube 108 passes through, and the distal end of the inner tube 108 is exposed to the distal end of the balloon 113. It will be appreciated that the distal end of the inner tube 108 is not located entirely within the chamber, but rather exposes a portion of the distal end of the balloon 113. In the portion of the inner tube 108 where the distal end of the balloon 113 is exposed, an imaging probe 106 is disposed, and the imaging probe 106 is connected to the spring tube 107 in the inner tube 108 by laser welding, bonding, or the like. The spring tube 107 can be configured as a single-layer or multi-layer structure, the spring tube 107 is connected to a driving structure 119 (see fig. 2, the driving structure and the high-voltage pulse output module can be integrally or separately arranged, and fig. 2 shows that the driving structure and the high-voltage pulse output module are integrally arranged), and the spring tube 107 is twisted under the driving force of the driving structure 119, so as to transmit the torque to the imaging probe 106, so that the imaging probe 106 moves. Movement includes, but is not limited to, the following: rotating and pulling back, wherein the rotation can be uniform rotation. The imaging probe 106 is driven by the driving structure 119 and the spring tube 107 to detect peripheral blood vessels and acquire imaging signals.

Electrodes

109, 110 may also be provided on the outer surface of the inner tube 108 within the balloon 113, and the electrodes may be paired (109, 110 are a pair of electrodes). At least one pair of

electrodes

109 and 110 is disposed on the outer surface of the inner tube 108, each pair of

electrodes

109 and 110 is connected in series or in parallel, and each pair of

electrodes

109 and 110 can be connected to a high voltage pulse output module 119, so as to break down the conductive liquid at the

electrodes

109 and 110 under the driving of high voltage pulses (the voltage range may be 500V-5000V), thereby generating mechanical shock waves in the balloon 113. The mechanical shock wave can break up the calcified plaque on the superficial layer and the deep layer of the blood vessel cavity, so that the blood vessel cavity is fully expanded. Therefore, the intravascular imaging shockwave balloon catheter shown in the present embodiment can perform intravascular imaging on a diseased blood vessel and can also perform shockwave therapy. Therefore, the operation of doctors can be facilitated, the operation time is shortened, unnecessary medical instruments are further reduced, the flow of the shock wave treatment operation is obviously simplified, the injury of the operation to a patient can be reduced, and the economic burden of the patient is reduced.

In a preferred implementation, a guide wire lumen 101 may also be provided in the intravascular imaging shockwave balloon catheter, the guide wire lumen 101 being located in the inner lumen of the inner tube 108 for passage of a guide wire for guiding the intravascular imaging shockwave balloon catheter. The length of the guidewire lumen 101 can be set to 5-30mm. It will be appreciated that the guide wire may be advanced through the intravascular lesion and guide the intravascular imaging shockwave balloon catheter to the lesion. The guidewire lumen 101 is configured with a rapid exchange port 104, and the guide wire can be passed into or out of the guidewire lumen 101 through the rapid exchange port 104, thereby further reducing the diameter of the intravascular imaging shockwave balloon catheter. It should be noted that if the intravascular imaging shockwave balloon catheter is not provided with the guidewire lumen 101 provided with the quick-exchange port 104, the inner lumen of the inner tube 108 corresponds to the guidewire lumen.

In a preferred implementation, in the intravascular imaging shockwave balloon catheter, there may also be provided visualization rings 102, 103, the visualization rings 102, 103 being located on the inner or outer surface of the inner tube 108, the visualization rings 102, 103 may be made of radiopaque platinum-iridium alloy, and the visualization rings 102, 103 being used for visualization marking to mark the location of the intravascular imaging shockwave balloon catheter. Wherein the markers can be visualized by a Digital Subtraction Angiography (DSA) device.

In a preferred implementation, the imaging probe 106 is a cylindrical structure, the imaging probe 106 may be an ultrasonic imaging probe, the imaging probe 106 is connected to a signal line located in the spring tube 107, a distal end of the signal line is connected to the imaging probe 106, a proximal end of the signal line is connected to the imaging device 120 (shown in fig. 2), and the signal line is used for transmitting an imaging signal acquired by the imaging probe 106 to the imaging device 120 (shown in fig. 2). The inner tube 108, the spring tube 107 in the inner tube 108, and the signal line in the spring tube 107 all penetrate through the interior of the intravascular imaging shockwave balloon catheter. In the inner tube 108, and on a side of the imaging probe 106 near the distal end of the inner tube 108, a partition may be provided for limiting the position of the imaging probe 106 and preventing the imaging probe 106 from ineffective imaging.

In the intravascular imaging shockwave balloon catheter, an imaging lumen 105 may also be provided, the imaging lumen 105 being located in the inner lumen of the inner tube 108 and located at the proximal end of the guidewire lumen 101, the distal end of the balloon 113, the imaging lumen 105 being a lumen that houses the imaging probe 106. It will be appreciated that the imaging cavity 105 is a cavity structure inside the inner tube 108, and the imaging probe 106 may be located inside the imaging cavity 105. Alternatively, the imaging lumen 105 may not be provided and the imaging probe 106 may be located directly in the inner tube 108. The imaging lumen 105 may be welded to the guidewire lumen 101 and the balloon 113 using laser welding, heat fusion, or the like.

In a preferred implementation, the intravascular imaging shockwave balloon catheter further comprises

leads

111, 112, the

leads

111, 112 being located on the outer wall of the inner tube 108, the

leads

111, 112 communicating with the

electrodes

109, 110 and the high voltage pulse output module 119 for delivering high voltage pulses to the

electrodes

109, 110.

In a preferred implementation mode, the inner tube 108 is a multi-layer thin-walled tube with a groove on the surface, and the

wires

111 and 112 can be located in the groove of the inner tube 108, so that the diameter of the inner tube 108 can be reduced, and the inner tube 108 and the

wires

111 and 112 can be coated by using an ultrathin heat shrinkable tube or a thin-walled tube with a single-side wall thickness of 0.005-0.2 mm.

In a preferred implementation, the intravascular imaging shockwave balloon catheter further comprises: a catheter hub located at the proximal end of outer tube 114 and coupled to outer tube 114, the catheter hub comprising: catheter hub filling lumen 115 and catheter hub connection lumen 116; the catheter base connecting cavity 116 is connected with the catheter base filling cavity 115, and the catheter base filling cavity 115 is used for injecting conductive liquid between the outer tube 114 and the inner tube 108 after air in the intravascular imaging shock wave balloon catheter is exhausted; it is understood that the conductive liquid is also filled in the balloon 113. A conductive liquid, including but not limited to one of: saline, a contrast agent, and a mixed solution of saline and a contrast agent.

Taking an application scenario of the intravascular imaging shockwave balloon catheter as an example for explanation, before performing shockwave treatment, a doctor first preliminarily determines parameters such as a calcified lesion position and a calcified blood vessel diameter of a patient through Digital Subtraction Angiography (DSA). And then selecting an intravascular imaging shock wave balloon catheter with a proper diameter and working length. Under the navigation of Digital Subtraction Angiography (DSA), the intravascular imaging shock wave balloon catheter is placed in the area near the position of the calcified lesion for intravascular imaging, and detailed data of the calcified lesion are obtained. Then under the guidance of intravascular imaging, the shock wave electrode is accurately placed in a calcified lesion area, the balloon is expanded, and shock wave treatment is carried out on the calcified lesion. After the shock wave treatment, intravascular imaging is performed again, and whether the calcified lesion is opened or not is judged, so that the method is suitable for subsequent operations such as stent implantation and the like. Therefore, the intravascular imaging and the shock wave treatment are combined, so that the operation of a doctor can be facilitated, the operation time is shortened, the use of unnecessary surgical medical instruments is further reduced, the flow of the shock wave treatment operation is obviously simplified, the injury of the operation to a patient can be reduced, and the economic burden of the patient is reduced.

An embodiment of the present invention further provides a medical apparatus, as shown in fig. 2, the medical apparatus includes the intravascular imaging shockwave balloon catheter shown in the previous embodiment, and in addition, the medical apparatus further includes: a high voltage pulse output module 119, an imaging device 120, and a driving structure 119.

The intravascular imaging shockwave balloon catheter further comprises: the catheter adapter 118 and the catheter extension tube 117, wherein the catheter adapter 118 is connected with the catheter base connecting cavity 116 through the catheter extension tube 117; the catheter adapter 118 is adapted to connect to at least one of a drive structure 119, a high voltage pulse output module 119, and an imaging device 120. The high voltage pulse output module 119 is configured to deliver high voltage pulses to the electrodes 109 and 110 (shown in fig. 1) through the wires 111 and 112 (shown in fig. 1); the output voltage range of the high voltage pulse output module 119 may be 500V to 5000V, and the pulse width may be 1 to 100 microseconds. The driving structure 119 is connected to the pogo pin 107 (shown in fig. 1) for driving the imaging probe 106 (shown in fig. 1) to move (rotate, pull back) through the pogo pin 107, and the imaging device 120 is connected to the signal line for receiving the imaging signal acquired by the imaging probe 106. It should be noted that the driving structure 119, the imaging device 120, and the high voltage pulse output module 119 may be integrally configured or may be independently configured, but the present invention is not limited thereto, and in the embodiment shown in fig. 2, the high voltage pulse output module 119 and the driving structure 119 are integrally configured, and the imaging device 120 is independently configured.

Compared with the prior art, the medical equipment provided by the embodiment of the invention breaks through the single function of the traditional shock wave balloon catheter, and can perform intravascular imaging and shock wave treatment on a diseased blood vessel by utilizing the imaging probe and the spring tube and combining the driving structure, the imaging device and the high-voltage pulse output module. Therefore, the operation of doctors can be facilitated, the operation time is shortened, unnecessary medical instruments are further reduced, the flow of the shock wave treatment operation is obviously simplified, the injury of the operation to a patient can be reduced, and the economic burden of the patient is reduced.

While the present invention has been described with reference to the particular illustrative embodiments, it is to be understood that the invention is not limited to the disclosed embodiments, but is intended to cover various modifications, equivalent arrangements, and equivalents thereof, which may be made by those skilled in the art without departing from the spirit and scope of the invention as defined by the appended claims.

Claims

1. An intravascular imaging shockwave balloon catheter, comprising:

an outer tube;

2. The balloon catheter of claim 1, further comprising:

the signal line is arranged in the spring tube, the far end of the signal line is connected with the imaging probe, the near end of the signal line is connected with the imaging device, and the signal line is used for transmitting the imaging signal.

3. A balloon catheter according to claim 1, further comprising:

and the partition is arranged in the inner tube and on one side of the imaging probe close to the far end of the inner tube and is used for limiting the position of the imaging probe.

4. The balloon catheter of claim 1, further comprising:

the guide wire cavity is provided with a quick exchange port, is positioned in the inner cavity of the inner tube and is used for penetrating through a guide wire;

5. A balloon catheter according to claim 1, further comprising:

6. The balloon catheter of claim 1, further comprising:

7. The balloon catheter according to claim 6, wherein the inner tube is a multi-layer thin-walled tube with a groove on the surface, and the guide wire is positioned in the groove of the inner tube.

8. A balloon catheter according to claim 1, further comprising:

9. The balloon catheter of claim 8, further comprising:

the catheter adapter is connected with the catheter seat connecting cavity through the catheter extension pipe; the conduit adapter is configured to connect to at least one of: the driving structure, the high-voltage pulse output module and the imaging device.

10. The balloon catheter of any one of claims 1-9,

the imaging probe is an ultrasonic imaging probe.

11. A medical device comprising the balloon catheter of any one of claims 1-10, further comprising: the high-voltage pulse output module, the imaging device and the driving structure;

the driving structure is connected with the spring tube and is used for driving the imaging probe to move through the spring tube;